Friday, December 31, 2010

Hangover Prevention and Treatment

CC 2.0:  Sydney. Fireworks Newyear 2006. Opera House and Harbour.
January 02, 2007 at 21:40. By Rob Chandler.
Happy New Year!

Have fun and party safely. If you're planning to indulge, checkout this informative website:
    How To Prevent A Hangover

Lots of great tips, info, and a Dr. Oz video.

Champagne in the Freezer - Reminder Magnet

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2011 Predictions - Global Supply Chain

Checkout Bob Ferrari's Blog on Global Supply Chain Business Process and Technology for his series, Supply Chain Matters Top Ten Predictions for Global Supply Chains in 2011.

His well-considered thoughts appear in 3 installments:
Supply Chain Matters Top Ten Predictions for Global Supply Chains in 2011- Part One
Supply Chain Matters Top Ten Predictions for Global Supply Chains in 2011- Part Two
Supply Chain Matters Top Ten Predictions for Global Supply Chains in 2011- Part Three

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Global Supply Chain Management and International Logistics

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Wednesday, December 29, 2010

CDC Updates To Sexually Transmitted Disease Treatment - Podcast and more

Logo of the Centers for Disease Control and Pr...Image via WikipediaThe CDC (Centers for Disease Control and Prevention) updated their guidelines for the treatment of persons who have or are at risk for sexually transmitted diseases (STDs).

For more information, including podcast:   The CDC's 2010 STD Treatment Guidelines website

Read the CDC 2010 STD Treatment Guidelines published in the MMWR (pdf)

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Mayo Clinic Guide to Self-Care: Answers for Everyday Health Problems (Third Edition)

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Tuesday, December 28, 2010

What Is Your Flu IQ?

Eccch!  Flu season is starting, and some places in the world have bird flu.

Are you ready?  What's your flu IQ?

Flu IQ


         

For more information:
CDC Weekly Flu Map
CDC - Just about everything you want to know about the flu (influenza)
http://www.flu.gov/

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Monday, December 27, 2010

FDA Targets Tainted Dietary Supplements

You might recall, among the warnings and alerts recently issued, the FDA warned people to stop using Man Up Now, a product marketed for sexual enhancement, as it contains a variation of a drug ingredient found in Viagra that can lower blood pressure to a dangerous level.

The FDA intends to:
  • Send a letter to the dietary supplement industry, stressing its legal obligation to prevent tainted products from reaching the market, and emphasizing the possibility of criminal investigations against those who endanger public health by their involvement in tainted products.
  • Implement a new, rapid notification system for the public on the FDA web site to alert the public quickly to tainted products marketed as dietary supplements.
  • Put in place a mechanism for industry to alert the FDA about the tainted products and the firms involved.
Source:  The FDA on Tainted Products Marketed as Dietary Supplements
The Pill Book Guide to Natural Medicines: Vitamins, Minerals, Nutritional Supplements, Herbs, and Other Natural Products (Kindle Edition)

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Friday, December 24, 2010

ICH Celebrates 20th Anniversary - Refreshes Website

Congratulations to The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as they celebrate their 20th anniversary.

The ICH website has been redesigned for better usability and sports new branding.

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You might also be interested in:
International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference

Thursday, December 23, 2010

Homeland Security Cracks Down On Counterfeit Drugs

Seal of the United States Department of Homela...Image via WikipediaI'm glad to see that the Department of Homeland Security is stepping up efforts to combat counterfeit drugs, according to this news release, PhRMA Statement on Department of Homeland Security Efforts to Crack Down on Counterfeiting Crimes.

PhRMA states:  "The most common mechanism for counterfeit drugs to enter the U.S. drug supply is through purchases made on illegal online pharmacy sites that are operated by criminals in other countries with known counterfeiting problems. Cracking down on these illegal sites can help protect patient safety and help ensure that the closed U.S. drug supply system is not compromised."

For more information on the danger of imported drugs

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Wednesday, December 15, 2010

More Aspirin Benefit - Cancer Prevention - I Love It

I started taking a daily dose of aspirin well over a decade ago, in hopes that the anecdotes of cancer prevention benefit would one day morph into evidence-based data. Voila!



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Tuesday, December 14, 2010

Monday, December 13, 2010

2011 Pharma Trends

It's that time of year again.

Brandon says, in Global Pharmaceutical Market Expected to Rebound in 2011:

  • the global pharmaceutical market will experience 5% to 7% growth in the coming year, compared with only 4% to 5% in 2010.
Patents for Chemicals, Pharmaceuticals and Biotechnology: Fundamentals of Global Law, Practice and Strategy

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Monday, December 6, 2010

Daily Truvada Lowers AIDS Risk

Estimated HIV/AIDS prevalence among young adul...Image via WikipediaThe New York Times reports, Daily Pill Greatly Lowers AIDS Risk, Study Finds.

Promising results found that the men taking Truvada, a common combination of two antiretroviral drugs, were 44 percent less likely to get infected with the virus that causes AIDS than an equal number taking a placebo.

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Saturday, December 4, 2010

National Flu Vaccination Week

It's here, National Influenza Vaccination Week. Check out the CDC's National Influenza Vaccination Week website for information and more resources.

I'm starting to see and hear reports of the flu season starting. On my public transportation trips, I'm aware that more folks around me are coughing and sneezing, so make sure your vaccinations are up to date.

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Wednesday, December 1, 2010

World AIDS Day - Bewildering Number of Official Websites

Today is World AIDS Day. If you Google it, you'll end up finding a dizzying array of websites proclaiming to be the official website for the Day.

Here's my contribution to the conversation. I recommend this helpful US Government site, AIDS.gov.  The opening line on the site just about sums up what they offer, "An estimated 1.1 million Americans are living with HIV, and yet one out of five don’t know it. World AIDS Day (December 1) is an opportunity for us to take action! Here are a few simple, powerful, and engaging ways:..."

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Tuesday, November 30, 2010

FDA Home Use Device Initiative

On the Designated Representative and Exemptee Blog - News On FDA Home Use Device Initiative: the FDA may suggest devicemakers create different written instructions for the patient, prescriber of the device and the person training the consumer on how to use the device.

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Tuesday, November 23, 2010

Turkey Talk - Avoid Getting Sick

Thanksgiving is here. I'm reprising one of my oldie but goodie posts, Time To Talk About Turkey Cooking and Food Safety.  Follow the link to a well written set of do's and don'ts.  As a bonus there are additional links that might pique your interest.

For fewer clicks, here's the real 'meat' of the matter:
Let's Talk Turkey—A Consumer Guide to Safely Roasting a Turkey

Enjoy your safe, and well-prepared Turkey dinner!

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Monday, November 22, 2010

10 Golden Rules of GMP - Free Tips

Updated October 3, 2018

The white paper referenced in the original post is no longer available.

However, PharmOut has posted this PDF:
The 10 Golden Rules of GMP - PharmOut

- -  original post follows below  - -

This free GMP white paper from PharmOut is a great read, White Paper - The 10 Golden Rules of GMP (pdf).

You get a quick list of the 10 golden rules, an excellent explanation of each rule, and finally a self-audit checklist.

Enjoy!

#FDA #GMP #training #cGMP

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Monday, November 15, 2010

Drugs and Supplements From China Still Largely Unregulated

Probably not surprising, and certainly disappointing, as reported by this KansasCity.com news article, Drugs, supplements come to U.S. from China largely unregulated.

I'm most concerned about, "One consequence of the lack of regulation has been a rising number of counterfeit drugs."

Related links:
GAO Report Blasts FDA for Failure to Implement 2008 Recommendations

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Wednesday, November 10, 2010

Shocking FDA Images For Cigarette Packages

Wow! These are high impact and jarring images. You have to check out what the FDA is proposing as new required warnings, consisting of nine new textual warning statements accompanied by color graphics depicting the negative health consequences of smoking, Proposed FDA Graphic Health Warnings for Cigarette Packages and Advertisements (PDF).

More Information:
FDA Proposed Cigarette Product Warning Labels

Stop Smoking:
Quit Smoking Today (http://www.smokefree.gov/)
Nicoderm CQ Step 1 Clear Patch 14-pk.

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Monday, November 8, 2010

FDA GMP Books - Limited Previews

A Picture of a eBookImage via WikipediaI'm a big fan and user of many of Google's offerings. 

While wandering through Google Books, I ran across these limited previews of these three FDA GMP-related books. I thought you might be interested.  Although the previews are limited, there's certainly enough content that can be read for learning, and plenty to review if you're considering buying the book.

Interpretation of FDA's Quality System Regulations (QSR) With QSIT references By Medical Device School (Google books preview)

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Google books preview)

Good manufacturing practices for pharmaceuticals (Google books preview)

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Monday, November 1, 2010

Staying Alive - New AHA 2010 CPR Technique (video)

This is a major change.  Watch this video to learn about the American Heart Association (AHA) 2010 Guidelines for CPR.  The guidelines mention the song Stayin' Alive for the compression rate of 100 beats per minute. 



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Tuesday, October 26, 2010

AARP - Free Pill Identifier

Free Pill Identifier

You just can't have too many free online pill identifiers.

This one from AARP (Association for the Advancement of Retired Persons) is kind of nifty. I like the interactive interface, and suspect you will too.

Free online pill identifier from AARP

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#FDA #GMP #training #cGMP

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Monday, October 25, 2010

Aspirin Reduces Colon Cancer Risk

Aspirin-3D-vdWImage via WikipediaI was happy to hear about the latest findings suggesting that Aspirin May Reduce Risk of Colon Cancer (Video).

Both my parents had gastrointestinal cancers, so for the last 15 years or so, I've been taking a baby aspirin everyday, based on my sense that there was some suggestive evidence that it could be protective.

Here's to aspirin and colon health!

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The Colon Cancer Survivors' Guide, Second Edition: Living Stronger, Longer

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Monday, October 18, 2010

FDA INTERPOL IMPACT IIWA Bust Almost 300 Websites

The FDA participated in an effort to bust nearly 300 websites.

The U.S. Food and Drug Administration and other regulatory and international partners have completed the International Internet Week of Action (IIWA), a coordinated, cooperative effort to curb online sales and distribution of counterfeit and illicit medical products. IIWA took place between October 5-12, 2010.

The IIWA is an initiative sponsored by INTERPOL, the World Health Organization's International Medical Products Anti-Counterfeiting Task Force (IMPACT), and the Permanent Forum on International Pharmaceutical Crime, as well as national health and law enforcement agencies from 40 participating countries.

The goal of the IIWA is to protect the public health by increasing the public's awareness about the dangers and risks associated with purchasing drugs and medical devices from Internet websites, to identify the producers and distributors of counterfeit or otherwise illegal pharmaceutical products or medical devices, to target these individuals or businesses with civil or criminal action, and to seize counterfeit and illegal products and remove them from the supply chain.

294 Web sites that appeared to be engaged in the illegal sale of unapproved/misbranded drugs to U.S. consumers were targeted. A total of 274 have been suspended or no longer offer pharmaceuticals for sale. The FDA is working with its foreign counterparts to address the remaining 20 Web sites which continue to offer unapproved prescription drugs to U.S. consumers.

More from the FDA:  Buying Medicines Over the Internet


cGMP basics training for newbies and seasoned staff

#FDA #GMP #cGMP #training #course #class

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